Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
This study has been completed.
Sponsor:
British Columbia Cancer Agency
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00632190
First received: March 7, 2008
Last updated: January 27, 2010
Last verified: January 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening test to help doctors find cervical cancer sooner, when it may be easier to treat.
PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy or Pap testing.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Precancerous Condition |
Other: fluorophotometry Procedure: colposcopic biopsy Procedure: colposcopy Procedure: light-scattering spectroscopy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix [ Designated as safety issue: No ]
- Refinement of fluorescence spectroscopy for detection of cervical lesions via better classification of normal columnar tissue and non-neoplastic tissue with inflammation, and low- and high-grade squamous intraepithelial lesions [ Designated as safety issue: No ]
- Validation of wavelength selections for the spectroscopy device derived from in vitro measurements [ Designated as safety issue: No ]
- Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia [ Designated as safety issue: No ]
| Estimated Enrollment: | 1800 |
| Study Start Date: | January 2000 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using fluorescence and reflectance spectroscopy.
- To measure the reflection and fluorescence spectra in vivo of sites in the human cervix.
- To further refine fluorescence spectroscopy for detection of cervical lesions via better classification of normal columnar tissue and non-neoplastic tissue with inflammation, and low- and high-grade squamous intraepithelial lesions.
- Evaluate and validate the wavelength selections for the spectroscopy device derived from in vitro measurements.
- Determine the sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia.
OUTLINE: This is a multicenter study. Patients are stratified according to menopausal status and current treatment (premenopausal not on oral contraceptive pills [OCP] vs premenopausal on OCP vs postmenopausal not on hormone replacement therapy [HRT] vs postmenopausal on HRT).
- Diagnostic study: As part of routine colposcopic evaluation, patients undergo placement of the probe on 1 to 4 sites in the cervix for 2-5 minutes. Up to two colposcopically abnormal sites and two normal sites are biopsied. Blood is drawn for hormone levels. Fluorescence excitation and emission matrix (EEM) data and reflectance spectroscopic information is acquired from patients with an abnormal Papanicolaou smear.
- Screening study: Fluorescence EEM and reflectance spectroscopic information is acquired from patients with a history of normal Papanicolaou smears.
PROJECTED ACCRUAL: A total of 800 patients with abnormal Papanicolaou smears and 1000 subjects with normal Papanicolaou smears are accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
DISEASE CHARACTERISTICS:
- Referred to the Colposcopy clinic at Vancouver General Hospital, the MD Anderson Cancer Center, or the University of Texas at Austin
- Abnormal or normal Papanicolaou smear
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Pre or post-menopausal
- Not pregnant
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00632190 History of Changes |
| Other Study ID Numbers: | CDR0000581311, BCCR-C99-0441, C99-0441 |
| Study First Received: | March 7, 2008 |
| Last Updated: | January 27, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
Additional relevant MeSH terms:
|
Neoplasms Uterine Cervical Neoplasms Precancerous Conditions Cervical Intraepithelial Neoplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013